On December 1, 2015, the Human Pathogens and Toxins Regulations (HPTR) came into force and the Human Pathogens Importation Regulations (HPIR) was repealed. Unless you are excluded or exempted, you will need to apply for a licence under the Human Pathogens and Toxins Act (HPTA) to conduct controlled activities (possessing, handling, using, producing, storing, permitting any person access, transferring, importing, exporting, releasing, abandoning, disposing of a human pathogen or toxin). This licence requirement replaces the requirement to register under the HPTA. It should be noted that there is no fee for licensing activities under the HPTA (including applying for, amending, renewing, etc.).
If on December 1, 2015, you are performing controlled activities with human pathogens or toxins (including possessing, storing, transferring, and disposing) you must submit your licence application to the Public Health Agency of Canada (PHAC) between December 1, 2015 and February 29, 2016 (inclusive). By doing so you will be exempted from the HPTA and HPTR licence requirements until PHAC has provided you a decision on your licence application. Failure to submit your licence application by February 29, 2016 will make you subject to enforcement action under the HPTA.
If you would like to begin conducting controlled activities for the first time with human pathogens and toxins after December 1, 2015, you need to wait for the processing of your licence application before you can commence controlled activities with human pathogens and toxins. Failure to wait until your licence application is processed before conducting controlled activities will make you subject to enforcement action under the HPTA.
For further information, please refer to sections below.
Please contact us with any questions: PHAC.pathogens.pathogenes.ASPC@canada.ca
Information on requirements related to HPTA Security Clearance Program, including Frequently Asked Questions, Forms and link to the Security Sensitive Biological Agents (SSBAs)
Information on Pathogen and Toxins Licence as required under the Human Pathogens and Toxins Regulations (HPTR), including Types of Licences, application process and Plan for Administrative Oversight for Pathogens and Toxins in a Reasearch Setting - Required Elements and Guidance.
Provides a brief description of acts and regulations managed by the Centre for Biosecurity on behalf of the Public Health Agency of Canada, including program components, supporting activities, and the Statements of Administrative Intent (SAIs).
Standard and guidelines used by laboratory researchers and workers in facilities possessing, handling, storing or using pathogens and toxins.
Technical documents providing detailed descriptions of the hazardous properties of specific human pathogens or toxins and recommendations for work practices involving these agents.
Learning materials to support regulated parties including e-learning courses on the principles and practices of biosafety and biosecurity.
Information on the Centre for Biosecurity's Compliance and Enforcement under the Human Pathogens and Toxins Act (HPTA), Human Pathogens and Toxins Regulations (HPTR) and Health of Animals Act and associated regulations (HAA/HAR).
Advisories, Notifications and Directives related to containment requirements for a specific pathogen or group of pathogens.
Information on the Centre for Biosecurity.
Information on engagement opportunities and how to contact the Centre for Biosecurity.
Information on reporting and notification requirements for Licence Holders, Biological Safety Officers and persons conducting controlled activities authorized under a licence.